Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
31310P
Brand Name
Kendall
Version/Model Number
31310P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 31, 2023
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSD
Product Code Name
BINDER, ABDOMINAL
Public Device Record Key
c32c26fe-389f-459c-a366-07df24d221f5
Public Version Date
May 13, 2020
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
20884521177311
Quantity per Package
50
Contains DI Package
10884521177314
Package Discontinue Date
May 13, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |